HIV Drug Videx Side Effects Linked to Liver Problems: FDA
Published: February 2nd, 2010 • Comments: 2
Federal regulators are warning that the Bristol-Myers Squib HIV drug Videx appears to be linked to rare liver problems, known as non-cirrotic portal hypertension, which could be fatal for some users.
The Videx side effects warning was issued on January 29 by the FDA. The agency noted that it has received 42 adverse event reports among users of Videx and Videx EC involving the rare, but serious, liver disorder over the last 18 years. At least four of the patients died from bleeding or liver failure on Videx after developing the condition.
Videx (didanosine) is an antiretroviral drug marketed by Bristol-Myers Squib. It was first approved by FDA in 1991. In 2000, the FDA approved a delayed-release version called Videx EC. The drug belongs to a class of medications known as nucleoside analogues, and reduces the growth of HIV.
Non-cirrhotic portal hypertension is the result of restricted blood flow through a major vein in the liver. The blood backs up to veins in the esophagus, which become enlarge and distended. The enlarged veins can sometimes rupture, leading to serious bleeding and, potentially, death.
Despite the risk of Videx liver damage, the FDA says that the drug should stay on the market, because the benefits for HIV patients still outweigh the risks. The FDA is requiring new label warnings, as well as changes to the medication guide to alert users about the potential risk of the Videx side effects. The drug already has been known to cause liver toxicity when combined with some other antiretroviral medications, such as hydroxyurea and ribavirin.
The FDA recommends that doctors with patients taking Videx regularly monitor for signs of portal hypertension.
Comment by Etchell on 3 February 2010:
Hi, the Videx adverse events can be viewed here: http://www.fdable.com/aers/advanced_query/a37442304169
Comment by Marcos on 10 March 2010:
I am sitting here typing these words while managing daily what Videx has done to my liver > esophageal varices > AND a very enlarged spleen – another “side effect” of ingesting Videx not even mentioned anywhere in this study but certainly in my case ! – AND having to control HIV infection at the same time…
What i don’t agree with this FDA warning is the part that still suggests that is up to the doctor and the patient to make the final decision of starting or continuing the use of Videx; Based on my own experience with Videx, i would say that my liver became enlarged and non-cirrotic within a few months of use, followed by and enlarged spleen + portal hypertension, then bleeding esophageal varices, a very/very serious condition as explained to me by the first gastroenterologist i met.
When i first met the doctors/specialists some years ago concerning my condition, they all seemed confused and did not believe me when i told them repeatedly that i had been a very/very moderate alcoholic drinker my entire life and that, after re-testing, i had never been infected with Hepatitis C, so where did this cirrotic liver came from all of a sudden ? I immediately ascribed it to one or perhaps the entire HIV drug combo i was then taking, but the doctors still refused to accept my claims and started calling my condition “idiopathic cirrotic liver”.
Why would any patient or doctor even consider using Videx when there are so many other meds in the same drug classification available for treating HIV infection ?
And, let me not even get into the side effects ot the drug, Nadolol, that i now have to take daily to treat all problems caused by non-cirrotic hypertension due to Videx : easily out of breath, tiredness and most of all, feeling constantly COLD and shivery, even indoors at 72 degrees ! It feels literally like being tortured with coldness from October to May every year, as i live in Boston.
My suggestion, based on the above comments, is to everyone considering the use of Videx to stay away from this drug as it may wreck your liver for the rest of your life…Plus !